In this week’s edition of InnovationRx, Medline’s blockbuster IPO, Fred Moll’s surgical robotics investments, Forbes’ inaugural top hospitals list, and more. To get it in your inbox, subscribe here.Charlie Mills, Medline’s former CEO and a key member of its founding familyAFP via Getty ImagesMedical supplies giant Medline’s IPO is set to be this winter’s blockbuster–worth up to $55 billion. Documents for it also reveal for the first time the remaining stake of the Mills family, who founded the company in 19 ...

-- Submission covers multiple indications including general, urological, colorectal, gynecological and cardiac surgeries -- FORT LAUDERDALE, Fla., Dec. 08, 2025 (GLOBE NEWSWIRE) -- SS Innovations International, Inc. (the “Company” or “SS Innovations”) (Nasdaq: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announced that the Company submitted a 510(k) premarket notification to the United States Food a ...

Core Insights - Stereotaxis (STXS) has received FDA 510(k) clearance for its next-generation robotic system, GenesisX, which aims to enhance accessibility in endovascular surgical robotics [1][8] - The approval is expected to strengthen STXS's commercial trajectory by providing a scalable platform that appeals to a broader range of hospitals and cath labs [2][4] Company Developments - The GenesisX system features a compact design that eliminates the need for specialized wall shielding and structural changes, allowing for easier installation in existing cath labs [9][10] - STXS has initiated a limited launch of GenesisX in the U.S. and Europe to validate its performance in clinical settings while expanding its catheter options and imaging integration [10] - The company is positioning GenesisX as a flexible capital solution with various commercial pathways, including direct sales and lease options, to lower barriers for hospitals hesitant due to cost [11] Financial Performance - STXS has a market capitalization of $259.6 million and reported a 50% earnings surprise in the last quarter [5] - Year-to-date, STXS shares have increased by 6.6%, outperforming the industry growth of 4.1% [3] Industry Outlook - The global surgical robot systems market is projected to grow from $11.48 billion in 2024 to $23.13 billion by 2030, with a CAGR of 12.4% from 2025 to 2030, driven by technological advancements and a preference for minimally invasive procedures [12]

Core Insights - Intuitive Surgical's shares surged 28.5% in the past month due to strong third-quarter performance, showcasing 20% global procedure growth and increased adoption of the da Vinci 5 system [1][8] - Management raised full-year procedure guidance, enhancing investor confidence in sustained momentum [1] Performance Overview - The da Vinci procedures grew by 19% year-over-year, driven by benign general surgery in the U.S. and double-digit growth in gynecology and colorectal procedures internationally [5] - The Ion robotic-assisted bronchoscopy system saw a 52% increase in procedures and a 14% rise in utilization [5] - Approximately 67,000 procedures were performed using the da Vinci 5 system in Q3, up from 50,000 in Q2, indicating strong adoption [6] Growth Drivers - Domestically, benign general surgeries such as cholecystectomy and appendectomy are key growth engines, with after-hours and acute-care surgeries also contributing [9] - Internationally, benign general surgery (up 39%), colorectal (up 28%), hysterectomy (up 27%), and thoracic (up 26%) are leading growth, accounting for about 40% of non-U.S. da Vinci volumes [10] - The Ion platform is gaining clinical validation, showing higher diagnostic yields in lung biopsies compared to conventional methods [11] Future Trends - Management believes utilization growth is still in the early stages of the da Vinci 5 cycle, with hospitals redeploying older systems to expand access [12] - The company aims to drive continued adoption of focused procedures, secure broader regional clearances for da Vinci 5, and enhance surgical precision through digital technologies [13] Financial Estimates - Analysts have revised earnings per share estimates upward, with current estimates at $8.61 for the current fiscal year and $9.55 for the next, indicating year-over-year growth rates of 17.3% and 10.9% respectively [14] Challenges - GLP-1 drugs are negatively impacting bariatric surgery volumes, which fell at a high-single-digit rate in Q3 [16] - Competition in China is intensifying, with delays and budget constraints affecting system placements and pricing [16] - Gross margin contraction is a concern, with pro forma gross margin down 90 basis points year-on-year to 68% [17] Valuation Concerns - Despite recent gains, ISRG shares trade at a forward P/E of 59.47X, significantly higher than the industry average of 30.08X and its peers Stryker and Medtronic [18]

Core Insights - SS Innovations International, Inc. reported a significant revenue increase of 192.5% year-over-year, reaching $12.8 million in Q3 2025, primarily driven by higher sales of the SSi Mantra 3 surgical robotic system [1][6][11] Financial Performance - Q3 2025 revenue rose to $12.8 million from $4.4 million in Q3 2024, with a gross profit increase of 166.0% to $6.2 million [6][11] - Gross margin for Q3 2025 was 48.1%, down from 52.8% in Q3 2024 [6] - The net loss for Q3 2025 was $3.7 million, consistent with the net loss of $3.2 million in Q3 2024 [6][11] - For the first nine months of 2025, total revenue increased by 123.0% to $28.0 million compared to $12.5 million in the same period of 2024 [6][8] - Cumulative surgeries performed using the SSi Mantra reached 6,057, including 56 telesurgeries and 319 cardiac procedures [6][12] Business Highlights - The number of SSi Mantra installations in Q3 2025 totaled 27, a 350.0% increase from 6 installations in Q3 2024 [6][11] - The cumulative installed base of SSi Mantra systems reached 127 across seven countries [6][11] - The company has received regulatory approval for the SSi Mantra in seven countries and is preparing to enter the U.S. and European Union markets [4][12] Upcoming Developments - The company plans to submit a 510(k) premarket notification to the FDA in Q4 2025 and aims for CE marking certification in the EU in the first half of 2026 [4][12] - SS Innovations is scheduled to participate in investor conferences in November 2025, providing opportunities for management to engage with investors [9][10]

Core Viewpoint - Intuitive Surgical's stock has declined approximately 30% from its 52-week high, presenting a potential buying opportunity for investors interested in growth stocks within the medical-device sector [1] Group 1: Company Overview - Intuitive Surgical is a leader in surgical robotics, particularly known for its da Vinci surgical robot system, which enhances surgical safety and patient outcomes through less invasive procedures [2][3] - The company continues to see growth in the deployment of da Vinci systems, with 395 new systems placed in the second quarter of 2025, a 15.8% increase from 341 in the same period last year, bringing the total to 10,488 systems, a 14% year-over-year increase [4][5] Group 2: Revenue Sources - The primary revenue for Intuitive Surgical comes from consumable items used in surgeries, which account for approximately 60% of sales, while the sale of robots contributes less than 25% to the top line [6][7] - Services related to installation and maintenance of da Vinci systems also contribute to revenue, creating a recurring income model that is beneficial for the company [8] Group 3: Stock Valuation - Intuitive Surgical's current price-to-sales ratio is around 17x and its price-to-earnings ratio is nearly 60x, indicating a high valuation compared to traditional value investment metrics [9] - The company's five-year average price-to-sales ratio is approximately 18.6x, and the average price-to-earnings ratio is about 72.5x, suggesting that while the stock is not cheap, it is relatively cheaper than in the past [11] - Historical data shows that a 30% drawdown in stock price is not unusual, which may attract more aggressive growth investors [11][12]

Core Viewpoint - Intuitive Surgical is positioned to maintain its leadership in the surgical robotics market, despite recent stock declines and increasing competition [1][3]. Company Performance - Intuitive Surgical's stock has experienced a 26% decline from its peak earlier in the year, but it has delivered a remarkable 19,510% return since its IPO approximately 25 years ago [1][2]. - The company is currently in the process of rolling out its latest system, the da Vinci 5, which is expected to reach full deployment by the end of 2026 [3]. Product Development - The da Vinci 5 system features a new force feedback capability that enhances the surgical experience by allowing surgeons to apply less force, potentially resulting in reduced tissue damage and quicker recoveries [4]. - In the second quarter, 180 new da Vinci 5 systems were successfully placed, indicating a strong start for the product launch [5]. Market Competition - Intuitive Surgical faces competition from several large international companies, including Medtronic, Stryker, and Johnson & Johnson, which also offer robot-assisted surgical systems [2][3]. - The increasing number of competitors introduces uncertainty regarding the company's future performance, despite the potential success of the da Vinci 5 system [3].

Core Insights - SS Innovations International, Inc. has successfully completed a human factors validation study for its SSi Mantra surgical robotic system at Johns Hopkins Hospital, marking a significant milestone in its regulatory process [1][2] - The company plans to submit a 510(k) premarket notification to the FDA in the fourth quarter of 2025, aiming for potential market clearance in the first half of 2026 [1][3] - The SSi Mantra has a cumulative installed base of 125 systems across six countries, with over 6,000 surgical procedures performed to date [4] Company Overview - SS Innovations is focused on developing innovative surgical robotic technologies to make robotic surgery more affordable and accessible globally [5] - The SSi Mantra system features a modular design with advanced technology, including multiple robotic arms and a 3D 4K monitor, supporting various surgical specialties [6] Regulatory Pathway - The company has shifted from a De Novo request to a 510(k) regulatory pathway, which is expected to provide speed and cost advantages in the approval process [4] - RQM+, a MedTech-focused CRO, has been engaged to assist with the 510(k) submission [2]

Core Viewpoint - SS Innovations International, Inc. has appointed Naveen Kumar Amar as the new Chief Financial Officer, effective September 24, 2025, succeeding Dr. Vishwa Srivastava, who will continue as CEO for Asia Pacific [1][2][3]. Company Overview - SS Innovations is focused on developing innovative surgical robotic technologies aimed at making robotic surgery affordable and accessible globally [5]. - The company’s product offerings include the proprietary "SSi Mantra" surgical robotic system and the "SSi Mudra" surgical instruments, which support various surgical procedures, including robotic cardiac surgery [5]. Leadership Appointment - Naveen Kumar Amar brings over 25 years of global finance leadership experience across various industries and geographies, with expertise in financial accounting, reporting, planning, analysis, and corporate finance [2][3]. - Amar has previously held significant positions, including Global CFO for Munch Ado India Private Ltd. and Head of Finance & Commercial for SpiceXpress [2][3]. Strategic Vision - The company aims to expand the global presence of its advanced, cost-efficient surgical robotic systems, particularly the SSi Mantra [3]. - Amar expressed his commitment to democratizing access to advanced surgical robotic care and driving growth to deliver sustainable long-term shareholder value [3]. Product Details - The SSi Mantra surgical robotic system features a modular design with 3 to 5 robotic arms, an ergonomic surgeon command center, and advanced imaging capabilities [6]. - It has been clinically validated in India for over 100 different types of surgical procedures, showcasing its versatility and effectiveness [6].

Core Viewpoint - Stereotaxis will release its financial results for the second quarter of 2025 on August 7, 2025, and will host a conference call to discuss these results and corporate developments [1][2]. Company Overview - Stereotaxis is a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, focusing on the discovery, development, and delivery of robotic systems and solutions for interventional laboratories [4]. - The company's technology has been utilized to treat over 150,000 patients globally, enhancing patient care with robotic precision and safety [4]. Conference Call Details - The conference call will take place on August 7, 2025, at 4:30 p.m. ET, with dial-in numbers provided for both U.S. and international participants [2]. - A replay of the call will be available for one month following the event [3].